Identity
- Trade Name
- IS 3600 POSTERIOR TIP 5 PCS EUDAMED
- Device Name
- IS 3600 I/O 3D Scanner EUDAMED
- Model / Reference
- 6577894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00693856000173 EUDAMED
- Basic UDI-DI
- 0693856IOSGU EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Is 3600 Posterior Tip 5 Pcs by Dental Imaging Technologies Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0693856IOSGU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
- EUDAMED SRN
- US-MF-000017139
- Authorised Representative
- PaloDEx Group Oy FI-AR-000004955
Sources (1)
- EUDAMED cc4fcdbd-1074-4c0a-acdd-7d4fccd6f039 61 fields · synced Jun 19, 2026